ID

39716

Descrizione

Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003); ODM derived from: https://clinicaltrials.gov/show/NCT01353911

collegamento

https://clinicaltrials.gov/show/NCT01353911

Keywords

versioni (1)
  1. 12/02/20 12/02/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

12 febbraio 2020

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01353911

Inglese

Eligibility Hepatitis C, Chronic NCT01353911

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
has previously documented chronic hepatitis c genotype 1 (chc gt 1) infection
Descrizione

Chronic Hepatitis C Genotype

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
has hepatitis c virus (hcv) ribonucleic acid (rna value) ≥10,000 iu/ml
Descrizione

Hepatitis C virus RNA assay

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1272251
body weight ≥40 kg (88 lbs) and ≤125 kg (275 lbs)
Descrizione

Body Weight

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005910
absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver disease
Descrizione

Ascites Absent | Bleeding esophageal varices Absent | Hepatic Encephalopathy Absent | Signs and Symptoms Decompensated liver disease Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0155789
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0019151
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0037088
UMLS CUI [4,2]
C4075847
UMLS CUI [4,3]
C0332197
had a liver biopsy within 3 years of screening or between screening and day 1 with histology consistent with chc and no evidence of cirrhosis or hepatocellular carcinoma or no other cause for chronic liver disease (for participants with compensated cirrhosis, any liver biopsy demonstrating cirrhosis regardless of length of time since biopsy)
Descrizione

Biopsy of liver | Histology Consistent with Chronic Hepatitis C | Liver Cirrhosis Absent | Liver carcinoma Absent | Chronic liver disease | Etiology Other Absent | Compensated cirrhosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0524910
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0341439
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0205394
UMLS CUI [6,3]
C0332197
UMLS CUI [7]
C1608426
female of childbearing potential or a male with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
Descrizione

Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
for participants with compensated cirrhosis, evidence of cirrhosis without evidence of hepatocellular carcinoma (confirmed by ultrasound within 4 weeks prior)
Descrizione

Study Subject Compensated cirrhosis | Liver Cirrhosis Ultrasonography | Liver carcinoma Absent Ultrasonography

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1608426
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0041618
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0041618
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
is pregnant, breastfeeding, or plans to become pregnant or donate eggs
Descrizione

Pregnancy | Breast Feeding | Pregnancy, Planned | Ovum Donation Planned

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0242812
UMLS CUI [4,2]
C1301732
is human immunodeficiency virus (hiv) positive or known to be co-infected with hepatitis b virus
Descrizione

HIV Seropositivity | HBV coinfection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2242656
has received prior approved or investigational treatment for hepatitis c
Descrizione

Prior Therapy Hepatitis C | Investigational Therapy Hepatitis C

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0019196
has evidence of hepatocellular carcinoma or is under evaluation for hepatocellular carcinoma
Descrizione

Liver carcinoma | Evaluation Liver carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C2239176
for participants with compensated cirrhosis: alphafetoprotein level of ≥100 ng/ml
Descrizione

Study Subject Compensated cirrhosis | Alpha one fetoprotein measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1608426
UMLS CUI [2]
C0201539
has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
Descrizione

Malignant Neoplasms | Malignant Neoplasm Suspected

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
has evidence or history of chronic hepatitis not caused by hcv
Descrizione

Hepatitis, Chronic | Etiology Except Hepatitis C virus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0220847
is diabetic and/or hypertensive with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
Descrizione

Diabetic | Hypertensive | On examination - eye findings Clinical Significance | Retinal Diseases | Cotton wool spots | Disorder of the optic nerve | Retinal Hemorrhage | Abnormality Clinical Significance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0857121
UMLS CUI [3,1]
C0437530
UMLS CUI [3,2]
C2826293
UMLS CUI [4]
C0035309
UMLS CUI [5]
C0271053
UMLS CUI [6]
C0029132
UMLS CUI [7]
C0035317
UMLS CUI [8,1]
C1704258
UMLS CUI [8,2]
C2826293
has any known medical condition that could interfere with the patient's participation in and completion of the study
Descrizione

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
pre-existing psychiatric condition including but not limited to moderate or severe depression, suicidal or homicidal ideation or attempt, schizophrenia, psychosis, bipolar disorder, post traumatic stress disorder, or mania
Descrizione

Psychiatric problem Pre-existing | Moderate depression | Severe depression | Feeling suicidal | Homicidal thoughts | Suicide attempt | Homicide attempt | Schizophrenia | Psychotic Disorders | Bipolar Disorder | Post-Traumatic Stress Disorder | Mania

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1306597
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0588007
UMLS CUI [3]
C0588008
UMLS CUI [4]
C0424000
UMLS CUI [5]
C0455204
UMLS CUI [6]
C0038663
UMLS CUI [7]
C0277662
UMLS CUI [8]
C0036341
UMLS CUI [9]
C0033975
UMLS CUI [10]
C0005586
UMLS CUI [11]
C0038436
UMLS CUI [12]
C0338831
is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
Descrizione

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
member or family member of study staff
Descrizione

Member Research Personnel | Family member Research Personnel

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C0035173
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Similar models

Eligibility Hepatitis C, Chronic NCT01353911

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
has previously documented chronic hepatitis c genotype 1 (chc gt 1) infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
has hepatitis c virus (hcv) ribonucleic acid (rna value) ≥10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Body Weight
Item
body weight ≥40 kg (88 lbs) and ≤125 kg (275 lbs)
boolean
C0005910 (UMLS CUI [1])
Ascites Absent | Bleeding esophageal varices Absent | Hepatic Encephalopathy Absent | Signs and Symptoms Decompensated liver disease Absent
Item
absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver disease
boolean
C0003962 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0155789 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019151 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0037088 (UMLS CUI [4,1])
C4075847 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Biopsy of liver | Histology Consistent with Chronic Hepatitis C | Liver Cirrhosis Absent | Liver carcinoma Absent | Chronic liver disease | Etiology Other Absent | Compensated cirrhosis
Item
had a liver biopsy within 3 years of screening or between screening and day 1 with histology consistent with chc and no evidence of cirrhosis or hepatocellular carcinoma or no other cause for chronic liver disease (for participants with compensated cirrhosis, any liver biopsy demonstrating cirrhosis regardless of length of time since biopsy)
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0341439 (UMLS CUI [5])
C0015127 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1608426 (UMLS CUI [7])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity
Item
female of childbearing potential or a male with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Study Subject Compensated cirrhosis | Liver Cirrhosis Ultrasonography | Liver carcinoma Absent Ultrasonography
Item
for participants with compensated cirrhosis, evidence of cirrhosis without evidence of hepatocellular carcinoma (confirmed by ultrasound within 4 weeks prior)
boolean
C0681850 (UMLS CUI [1,1])
C1608426 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Ovum Donation Planned
Item
is pregnant, breastfeeding, or plans to become pregnant or donate eggs
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0242812 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
HIV Seropositivity | HBV coinfection
Item
is human immunodeficiency virus (hiv) positive or known to be co-infected with hepatitis b virus
boolean
C0019699 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Prior Therapy Hepatitis C | Investigational Therapy Hepatitis C
Item
has received prior approved or investigational treatment for hepatitis c
boolean
C1514463 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Liver carcinoma | Evaluation Liver carcinoma
Item
has evidence of hepatocellular carcinoma or is under evaluation for hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Study Subject Compensated cirrhosis | Alpha one fetoprotein measurement
Item
for participants with compensated cirrhosis: alphafetoprotein level of ≥100 ng/ml
boolean
C0681850 (UMLS CUI [1,1])
C1608426 (UMLS CUI [1,2])
C0201539 (UMLS CUI [2])
Malignant Neoplasms | Malignant Neoplasm Suspected
Item
has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Hepatitis, Chronic | Etiology Except Hepatitis C virus
Item
has evidence or history of chronic hepatitis not caused by hcv
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Diabetic | Hypertensive | On examination - eye findings Clinical Significance | Retinal Diseases | Cotton wool spots | Disorder of the optic nerve | Retinal Hemorrhage | Abnormality Clinical Significance
Item
is diabetic and/or hypertensive with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
boolean
C0241863 (UMLS CUI [1])
C0857121 (UMLS CUI [2])
C0437530 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0035309 (UMLS CUI [4])
C0271053 (UMLS CUI [5])
C0029132 (UMLS CUI [6])
C0035317 (UMLS CUI [7])
C1704258 (UMLS CUI [8,1])
C2826293 (UMLS CUI [8,2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial
Item
has any known medical condition that could interfere with the patient's participation in and completion of the study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Psychiatric problem Pre-existing | Moderate depression | Severe depression | Feeling suicidal | Homicidal thoughts | Suicide attempt | Homicide attempt | Schizophrenia | Psychotic Disorders | Bipolar Disorder | Post-Traumatic Stress Disorder | Mania
Item
pre-existing psychiatric condition including but not limited to moderate or severe depression, suicidal or homicidal ideation or attempt, schizophrenia, psychosis, bipolar disorder, post traumatic stress disorder, or mania
boolean
C1306597 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0588007 (UMLS CUI [2])
C0588008 (UMLS CUI [3])
C0424000 (UMLS CUI [4])
C0455204 (UMLS CUI [5])
C0038663 (UMLS CUI [6])
C0277662 (UMLS CUI [7])
C0036341 (UMLS CUI [8])
C0033975 (UMLS CUI [9])
C0005586 (UMLS CUI [10])
C0038436 (UMLS CUI [11])
C0338831 (UMLS CUI [12])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Member Research Personnel | Family member Research Personnel
Item
member or family member of study staff
boolean
C0680022 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0086282 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
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